75N95024Q00480 - CSS.pdf

NON-COMPETITIVE

COMBINED SYNOPSIS / SOLICITATION

Title: cGMP Mitragynine HCl Supplemental Stability & Analytical Activities

(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

(ii) The solicitation number is 75N95024Q00480 and the solicitation is issued as a request for quotation (RFQ).

This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures;

and FAR Part 12—Acquisition of Commercial Items, and is not expected to exceed the simplified acquisition threshold.

THIS IS A NON-COMPETITIVE (NOTICE OF INTENT) COMBINED SYNOPSIS

SOLICITATION TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT

PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Institute on Drug Abuse (NIDA), Office of Acquisition (OA), on behalf of the National Center for Advancing Translational Sciences (NCATS), intends to negotiate and award a purchase order without providing for full and open competition (including brand-name) to Curia Global, Inc., 26 Corporate Circle Albany, New York 12203 for cGMP Mitragynine HCl Supplemental Stability & Analytical Activities.

The justification for the sole source is that only Curia Global has the experience and understanding of the chemical and physical properties of Mitragynine HCl, and has the capability to handle and analyze or test Mitragynine HCl salt. The analytical methods have been developed and validated by Curia Global in a previous contract.

This acquisition is conducted as non-competitive for a commercial item or service and is conducted pursuant to FAR 13.106-1(b)(1).

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2024-05, with effective date 05/22/2024.

(iv) The associated NAICS code is 541380 - Testing Laboratories and Services and the small business size standard is $19.0 million. This requirement is non-competitive with no set-aside restrictions.

(v) This requirement is for the following services:

cGMP Mitragynine HCl Supplemental Stability & Analytical Activities

(vi) The Therapeutic Development Branch (TDB) at the National Center for Advancing

Translational Sciences (NCATS) is conducting a preclinical development of Mitragynine (MG) to support its clinical evaluation, as part of the Helping to End Addiction Long-term initiative (HEAL). The Contractor shall provide long term stability studies on two cGMP batches of Mitragynine HCl and requalify cGMP reference standard of Mitragynine HCl annually for up to 3 years. See Attachment 1 - Statement of Work.

(vii) The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the anticipated period of performance is 9/4/2024-9/3/2027.

(viii) The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998), applies to this acquisition. This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text.

Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at these addresses:

https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

(End of provision)

The following provisions apply to this acquisition and are incorporated by reference:

• FAR 52.204-7, System for Award Management (Oct 2018)

• FAR 52.204-16, Commercial and Government Entity Code Reporting (Aug 2020)

• FAR 52.204-29, Federal Acquisition Supply Chain Security Act Orders –

Representation and Disclosures (Dec 2023)

• FAR 52.212-1, Instructions to Offerors-Commercial Products and Commercial

Services (Sep 2023)

• FAR 52.212-3, Offeror Representations and Certifications-Commercial Products and Commercial Services (May 2024)

The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998), applies to this acquisition. This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at these addresses:

https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

The following clauses apply to this acquisition and are incorporated by reference:

• FAR 52.204-13, System for Award Management Maintenance (Oct 2018)

• FAR 52.204-18, Commercial and Government Entity Code Maintenance (Aug

2020)

• FAR 52.212-4, Contract Terms and Conditions-Commercial Products and

Commercial Services (Nov 2023). Addendum to this FAR clause applies to this acquisition and is attached.

• HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015)

The following provisions and clauses apply to this acquisition and are attached in full text. Offerors MUST complete the applicable provisions and submit completed copies as separate documents with their proposal.

• FAR 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021)

• FAR 52.204-26, Covered Telecommunications Equipment or Services- Representation (Oct 2020)

• FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Products and Commercial Services (May 2024)

• FAR 52.222-52, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Certification (May 2014)

• NIH Invoice and Payment Provisions

(ix) The Government will evaluate quotations or offers in accordance with FAR 13.106-2 and award a purchase order from this solicitation to the responsible offeror whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes:

a. Technical capability of the item offered to meet the Government requirement;

b. Price; and

c. Past performance [see FAR 13.106-2(b)(3)].

(x) Offerors must include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (May 2024), with its offer. If the offeror has completed FAR clause 52.212-3 at www.sam.gov, then the offeror does not need to provide a completed copy with its offer.

http://www.sam.gov/

(xi) There are no additional contract requirement(s) or terms and conditions applicable to this acquisition.

(xii) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.

(xiii) Responses to this solicitation must include clear and convincing evidence of the offeror’s capability of fulfilling the requirement as it relates to the technical evaluation criteria. The price proposal must include the price for each line item and the total price.

The Unique Entity ID from SAM.gov, the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

All quotations must be received by 12:00pm Eastern Daylight Time, on 15 August 2024, and reference Solicitation Number 75N95024Q00480. Responses must be submitted electronically to Sarah Adan, Contract Specialist at sarah.adan@nih.gov.

Fax responses will not be accepted.

http://www.sam.gov/

This acquisition is conducted as non-competitive for a commercial item or service and is conducted pursuant to FAR 13.106-1(b)(1).